BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOSI-FLOW 30

    MDR report key: 2903852 · Received December 28, 2012

    Report

    Report Number
    MW5028466
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 28, 2012
    Manufacturer
    VICTUS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS USING VICTUS BRAND DOSI FLOW 30 IV FLOW REGULATOR WITH IV ADULT SET IN THE HOME TO INFUSE HIS ANTIBIOTICS. MULTIPLE SETS OF TUBING WERE FLOWING MUCH SLOWER THAN RATE SET ON DIAL OR NOT AT ALL. PT WOULD HAVE TO INCREASE RATE TO ABOVE "OPEN" ON DIAL TO GET IT TO FLOW AT ALL. PT WAS ADVISED NOT TO USE TUBING ANY LONGER AS IT WAS NOT SAFE AS FLOW RATE COULD NOT BE ADEQUATELY CONTROLLED BY DIAL ON TUBING. DATES OF USE: (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: OSTEOMYELITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOSI-FLOW 30 IV ADULT SET FPA VICTUS 111667L

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other